SERM Medical Director
Il y a 17 heures
SintKatelijneWaver, Vlaanderen, Belgique
GSK
Temps plein
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Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more: Our approach to R&D
Position Summary
Provides medical and scientific leadership in the safety evaluation and risk management of GSK’s oncology assets in clinical development.
Responsible for the interpretation of safety data, identification and escalation of safety signals, and delivery of clear, evidence-based recommendations to support benefit–risk decisions. This role contributes to global governance and plays a critical part in protecting patient safety and shaping the safety profile of innovative oncology medicines.
Key Responsibilities
Scientific / Medical & Pharmacovigilance Expertise
Lead pharmacovigilance and risk management activities for assigned oncology assets and clinical trials
Define and drive strategy for the evaluation and management of safety issues across the clinical development lifecycle
Analyseand interpret clinical data, literature, and emerging evidence toidentifyand assess safety signals
Provide expert medical input into the safety components of global regulatory submissions
Apply sound clinical judgement to complex and sometimes conflicting data sets to inform benefit–risk decisions
Ensuretimelyescalation of safety concerns in line with governance processes
Matrix Leadership & Cross-functional Collaboration
Represent Safety on cross-functional Clinical Matrix and Project Teams
Lead cross-functional teams to address urgent and complex product safety issues
Actively contribute to and, whereappropriate, lead Safety Review Teams (SRTs)
Build strong, collaborative relationships across functions and geographies
Coach and mentor colleagues, contributing to capability development within theorganisation
Ensure effective communication and alignment with Safety Leads, senior SERM leadership, and key stakeholders
Communication, Influence & Governance
Lead presentations on safety issues and recommendations to senior governance committees
Influence decision-making through clear, credible, and evidence-based communication
Represent GSK in interactions with regulatory authorities, external experts, and partners
Contribute to the development of safety strategy for clinicalprogrammesand broader SERM activities
Identifyopportunities to improve processes, drive innovation, and enhance operational effectiveness
Operate with strong awareness of the internal and external regulatory and scientific environment
Why Join Us? This is an opportunity to play a pivotal role in advancing GSK’s oncology pipeline, withdirectimpact on patient safety and global health outcomes.
You will:
Shape the safety strategy of innovative oncology medicines
Engage with senior governance and influence key development decisions
Work within a highly collaborative, global matrix environment
Contribute to scientific excellence and continuous improvement in safety science
Basic Qualifications
Medical degree with current GMC registration (or eligibility topractisein the UK) and relevant clinical experience
Completion of formal postgraduate clinical training (e.g., residency or specialty training)
Significant experiencein pharmacovigilance, drug safety, or medical affairs
Demonstratedexpertisein signal detection, evaluation, and risk management
Strong understanding of clinical development and post-marketing safety processes
Experience working effectively in matrixed, cross-functional environments
Excellent written and verbal communication skills, including preparation of medical and regulatory documents
Strong clinical judgement and the ability to deliver clear, evidence-based recommendations
Preferred Qualifications
Postgraduatespecialisationin a clinical discipline or pharmaceutical medicine
Experience contributing to regulatory submissions and periodic safety reports
Knowledge of epidemiology, biostatistics, or real-world evidence relevant to safety assessment
Experience leading Safety Review Teams or acting as safety lead for majorprogrammes
Prior en
Find out more: Our approach to R&D
Position Summary
Provides medical and scientific leadership in the safety evaluation and risk management of GSK’s oncology assets in clinical development.
Responsible for the interpretation of safety data, identification and escalation of safety signals, and delivery of clear, evidence-based recommendations to support benefit–risk decisions. This role contributes to global governance and plays a critical part in protecting patient safety and shaping the safety profile of innovative oncology medicines.
Key Responsibilities
Scientific / Medical & Pharmacovigilance Expertise
Lead pharmacovigilance and risk management activities for assigned oncology assets and clinical trials
Define and drive strategy for the evaluation and management of safety issues across the clinical development lifecycle
Analyseand interpret clinical data, literature, and emerging evidence toidentifyand assess safety signals
Provide expert medical input into the safety components of global regulatory submissions
Apply sound clinical judgement to complex and sometimes conflicting data sets to inform benefit–risk decisions
Ensuretimelyescalation of safety concerns in line with governance processes
Matrix Leadership & Cross-functional Collaboration
Represent Safety on cross-functional Clinical Matrix and Project Teams
Lead cross-functional teams to address urgent and complex product safety issues
Actively contribute to and, whereappropriate, lead Safety Review Teams (SRTs)
Build strong, collaborative relationships across functions and geographies
Coach and mentor colleagues, contributing to capability development within theorganisation
Ensure effective communication and alignment with Safety Leads, senior SERM leadership, and key stakeholders
Communication, Influence & Governance
Lead presentations on safety issues and recommendations to senior governance committees
Influence decision-making through clear, credible, and evidence-based communication
Represent GSK in interactions with regulatory authorities, external experts, and partners
Contribute to the development of safety strategy for clinicalprogrammesand broader SERM activities
Identifyopportunities to improve processes, drive innovation, and enhance operational effectiveness
Operate with strong awareness of the internal and external regulatory and scientific environment
Why Join Us? This is an opportunity to play a pivotal role in advancing GSK’s oncology pipeline, withdirectimpact on patient safety and global health outcomes.
You will:
Shape the safety strategy of innovative oncology medicines
Engage with senior governance and influence key development decisions
Work within a highly collaborative, global matrix environment
Contribute to scientific excellence and continuous improvement in safety science
Basic Qualifications
Medical degree with current GMC registration (or eligibility topractisein the UK) and relevant clinical experience
Completion of formal postgraduate clinical training (e.g., residency or specialty training)
Significant experiencein pharmacovigilance, drug safety, or medical affairs
Demonstratedexpertisein signal detection, evaluation, and risk management
Strong understanding of clinical development and post-marketing safety processes
Experience working effectively in matrixed, cross-functional environments
Excellent written and verbal communication skills, including preparation of medical and regulatory documents
Strong clinical judgement and the ability to deliver clear, evidence-based recommendations
Preferred Qualifications
Postgraduatespecialisationin a clinical discipline or pharmaceutical medicine
Experience contributing to regulatory submissions and periodic safety reports
Knowledge of epidemiology, biostatistics, or real-world evidence relevant to safety assessment
Experience leading Safety Review Teams or acting as safety lead for majorprogrammes
Prior en